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History of Changes for Study: NCT02566655
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)
Latest version (submitted October 7, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 30, 2015 None (earliest Version on record)
2 October 2, 2015 Study Status and Study Identification
3 January 12, 2016 Outcome Measures, Study Status, Contacts/Locations, Arms and Interventions, Eligibility, Study Description, Sponsor/Collaborators and Study Identification
4 March 29, 2017 Study Status, Contacts/Locations and Sponsor/Collaborators
5 June 1, 2017 Sponsor/Collaborators, Contacts/Locations and Study Status
6 January 9, 2020 Recruitment Status, Study Status and Contacts/Locations
7 October 7, 2020 Recruitment Status and Study Status
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Study NCT02566655
Submitted Date:  September 30, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: CSM/OP/2011
Brief Title: Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)
Official Title: PHASE I CLINICAL TRIAL TO EVALUATE THE INTRAVENOUS INFUSION OF AUTOLOGOUS FUCOSYLATED BONE MARROW MESENCHYMAL CELLS THERAPY IN PATIENTS WITH ESTABLISHED OSTEOPOROSIS WITH VERTEBRAL FRACTURE
Secondary IDs: 2012-005814-20 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2015
Overall Status: Recruiting
Study Start: September 2015
Primary Completion: May 2016 [Anticipated]
Study Completion: September 2018 [Anticipated]
First Submitted: January 30, 2015
First Submitted that
Met QC Criteria:
September 30, 2015
First Posted: October 2, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 30, 2015
Last Update Posted: October 2, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Red de Terapia Celular
Responsible Party: Sponsor
Collaborators: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Spanish National Health System
Public Health Service, Murcia
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis and with a vertebral fracture by a prospective, single-center, open, non-randomized and unblinded clinical trial.
Detailed Description:
Open or close this module Conditions
Conditions: Osteoporosis
Spinal Fractures
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 10 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Fucosylated MSC for Osteoporosis
Autologous Bone Marrow mesenchymal stem cells fucosylated be infused intravenously on Day 0, at unique doses 2,0-2,5 million cells/Kg of patient weight, optimal final volume: 20-60 mL depending on the corresponding dose.
Biological: Fucosylated MSC for Osteoporosis

30 days before infusion, bone marrow of patients included in the clinical trial is obtained. The bone marrow will be obtained according to standard practice for Hematologists of the Haematology University Hospital Virgen de la Arrixaca (HCUVA).

Mononuclear bone marrow cells were separated and cultured in GMP conditions to established dose range. The day of infusion, around three hours before, cells will come off as usual procedure and will be subjected to the process of fucosylation.

The fucosylated cells are resuspended in saline to a concentration of 5 million cells per 1 mL. Then, the final product will be packaged in 60 mL syringes for intravenous administration in patients through a peripheral venous access at a controlled rate of 4-6mL / minute, using an infusion pump.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of serious and non-serious adverse events related to the procedure.
[ Time Frame: 24 months from baseline ]

During time frame the following items will be considered:

Adverse effects related to the infusion moment. Occurrence of infectious complications after infusion of mesenchymal stem cells, because of the immunosuppressive effect of these cells.

Appearance of procedure-related neoplasias.

Secondary Outcome Measures:
1. Number of new fractures
[ Time Frame: 24 months from baseline ]

2. Pain, as measured by Visual Analog Scale
[ Time Frame: 24 months from baseline ]

To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable.
3. Functionality, as measured by Oswestry Disability Questionnaire
[ Time Frame: 24 months from baseline ]

To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used.
4. Quality of Life, as measured by EuroQoL-5D test
[ Time Frame: 24 months from baseline ]

To measure the quality of life EuroQoL-5D psychometric test is used.
5. Bone resorption, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
6. Bone formation, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
7. Bone formation, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
8. Bone formation, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
9. Bone metabolism, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
10. Bone metabolism, measured by biochemical index
[ Time Frame: 24 months from baseline ]

Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
11. Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
[ Time Frame: 24 months from baseline ]

12. Bone structure, measured by histomorphometric evaluation
[ Time Frame: 24 months from baseline ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 70 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients with established osteoporosis treated with percutaneous vertebroplasty subsidiary fracture according to standard clinical criteria.
  • Patients without contraindications for an epidural and vertebroplasty.
  • Patients who offer sufficient guarantees of adherence to protocol.
  • Patients who give their written informed consent to participate in the study consent.
  • Meet all the inclusion criteria

Exclusion Criteria:

  • Patients with concomitant systemic disease in the opinion of the investigator.
  • Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis.
  • Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin.
  • Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
  • Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation.
  • Transplant patients: bone marrow, kidney, liver, heart, lung.
  • Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction.
  • Patients participating in a clinical trial in the last 6 months.
  • Patients with positive serology for hepatitis B, hepatitis C or HIV.
  • Patients with inability to understand informed consent.
  • Patients who are pregnant or breast-feeding actively.
  • Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
Open or close this module Contacts/Locations
Central Contact Person: Natalia García Iniesta
Telephone: +34968381221
Email: nagarini@yahoo.es
Study Officials: Luis F Linares Ferrando, MD
Principal Investigator
Hospital Universitario Virgen de la Arrixaca
Locations: Spain, Murcia
Hospital Clínico Virgen de la Arrixaca
[Recruiting]
El Palmar, Murcia, Spain, 30120
Contact:Contact: Natalia García Iniesta +34968381221 nagarini@yahoo.es
Contact:Principal Investigator: Luis F Linares Ferrando, MD
Contact:Sub-Investigator: Carlos Marras Fernández-Cid, MD
Contact:Sub-Investigator: José M Moraleda Jiménez, MD
Contact:Sub-Investigator: Miguel Blanquer Blanquer, MD
Contact:Sub-Investigator: Ana M García Hernández, MD
Contact:Sub-Investigator: Joaquín A Gómez Espuch, MD
Contact:Sub-Investigator: Valentín Cabañas Perianes, MD
Contact:Sub-Investigator: Antonio Moreno Diéguez, MD
Contact:Sub-Investigator: Isabel Tovar Zapata, MD
Contact:Sub-Investigator: María Dolores López Lucas, Graduate
Contact:Sub-Investigator: Darío Sánchez Salinas, Graduate
Contact:Sub-Investigator: Francisca Iniesta Martínez, Graduate
Contact:Sub-Investigator: Carmen Algueró Martín, Graduate
Contact:Sub-Investigator: Ernesto Doménech Abellán, MD
Contact:Sub-Investigator: María L Mariñoso Barba, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
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